"The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product appr"...
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Details with Side Effects
To minimize the risk of induced arrhythmia, patients initiated or re-initiated on BETAPACE AF (sotalol hcl) ® should be placed for a minimum of three days (on their maintenance dose) in a facility that can provide cardiac resuscitation, continuous electrocardiographic monitoring and calculations of creatinine clearance. For detailed instructions regarding dose selection, and special cautions for people with renal impairment, see DOSAGE AND ADMINISTRATION. Sotalol is also indicated for the treatment of documented life-threatening ventricular arrhythmias and is marketed under the brand name BETAPACE®. BETAPACE however, should not be substituted for BETAPACE AF (sotalol hcl) because of significant differences in labeling (i.e. patient package insert, dosing administration and safety information).
BETAPACE AF (sotalol hcl) , (sotalol hydrochloride), is an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. It is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l-N-[4-[1- hydroxy-2-[(1-methylethyl)amino]ethyl]phenyl]methanesulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S•HCl and is represented by the following structural formula:
What are the possible side effects of sotalol AF (Betapace AF, Sotalol Hydrochloride AF)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- fast or pounding heartbeat, chest pain, shortness of breath;
- feeling light-headed, fainting;
- slow heartbeat;
- unusual sweating, increased thirst; or
- swelling, rapid weight gain.
Less serious side effects may include:
- mild diarrhea, nausea,...
What are the precautions when taking sotalol hcl (Betapace AF)?
See also Warning section.
Before taking sotalol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain heart rhythm problems (such as a slow heartbeat, second- or third-degree atrioventricular block unless you have a heart pacemaker), severe heart failure, breathing problems (such as asthma, chronic bronchitis, emphysema).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney...
Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Betapace AF Information
Betapace AF - User Reviews
Betapace AF User Reviews
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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